MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-01 for MAYFIELD HEADREST manufactured by .
[18850408]
A (b)(6) female admitted on (b)(6) 2012 for elective posterior cervical fusion for cervical laminectomy of c3-7. Pt was in prone position and in mayfield headrest; upon completion of surgery and putting pt on stretcher, a 1? Inch laceration noted to back of head. Surgeon notified and laceration closed with staples. Mayfield headrest tagged and taken out of service and biomed contacted. Thus far no evidence to suggest product defect but felt to be due to user error but no confirmation of such exists.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025667 |
| MDR Report Key | 2603290 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-05-10 |
| Date Added to Maude | 2012-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MAYFIELD HEADREST |
| Product Code | HBM |
| Date Received | 2012-06-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-01 |